This table shows all Adverse Drug Reactions reported to the FDA's Adverse Event Reporting System between 2004 and the 2nd Quarter of 2008 where the listed psychiatric drug was identified as the Primary Suspect Drug (FDA's term) deemed responsible for causing or inducing these reactions and where one or more of the Adverse Reactions reported for the Case described a congenital, prenatal or neonatal condition. Where no Age, Date of Event or Indication (the condition being treated) are shown, none were present in the FDA records.

Reported By: CN-Consumer, LW-Lawyer, MD-Physician, OT-Other Healthcare Provider, PH-Pharmacist, Blank-Not Reported in ISR (Individual Safety Report).

The Oxford English Dictionary defines a poison as "a substance that causes death or harm when introduced into or absorbed by a living organism."  This psychiatric drug fits that definition.

Anafranil (clomipramine), Clomipramine (clomipramine)

Abortion Spontaneous, Agitation, Agitation Neonatal, Alpha 1 Foetoprotein Increased, Apgar Score Low, Apnoeic Attack, Autism, Base Excess Decreased, Base Excess Negative, Blood Alcohol Increased, Blood Lactic Acid Increased, Blood PH Decreased, Blood Pressure Increased, Caesarean Section, Cardiac Murmur, Cardiac Ventricular Disorder, Cerebral Cyst, Cerebral Haematoma, Cerebral Haemorrhage Neonatal, Cerebral Ischaemia, Cerebral Ventricle Dilatation, Clonus, Coma, Complications of Maternal Exposure To Therapeutic Drugs, Congenital Acrochordon, Congenital Anomaly, Congenital Atrial Septal Defect, Congenital Cerebral Cyst, Congenital Hydrocephalus, Constipation, Convulsion, Convulsion Neonatal, Crying, Cyanosis Neonatal, Deafness Congenital, Death, Dehydration, Depressed Level of Consciousness, Depression, Developmental Coordination Disorder, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Screen Positive, Drug Toxicity, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Dyspepsia, Ear Malformation, Electrocardiogram QRS Complex Shortened, Extrapyramidal Disorder, Facial Dysmorphism, Fallot's Tetralogy, Feeding Problem In Newborn, Fever Neonatal, Foetal Cardiac Disorder, Foetal Disorder, Foetal Valproate Syndrome, Food Intolerance, Forceps Delivery, Gastrointestinal Disorder Congenital, Gastrooesophageal Reflux Disease, Gestational Diabetes, Growth Retardation, Habitual Abortion, Hepatocellular Damage, Hepatomegaly, Hereditary Ataxia, Holt-Oram Syndrome, Hyperammonaemia, Hypertonia, Hypertonia Neonatal, Hypoglycaemia Neonatal, Hypospadias, Hypotension, Hypotonia Neonatal, Inborn Error of Metabolism, Intentional Overdose, Intercostal Retraction, Irritability, Jaundice Neonatal, Joint Hyperextension, Laboratory Test Abnormal, Maternal Drugs Affecting Foetus, Micrognathia, Miosis, Movement Disorder, Neonatal Apnoeic Attack, Neonatal Asphyxia, Neonatal Aspiration, Neonatal Disorder, Neonatal Hepatomegaly, Neonatal Respiratory Acidosis, Neonatal Respiratory Depression, Neonatal Tachycardia, Neonatal Tachypnoea, Nephrotic Syndrome, Oculocephalogyric Reflex Absent, Opisthotonus, Pancreatic Disorder, PCO2 Increased, Placenta Praevia, Placenta Praevia Haemorrhage, Platelet Count Increased, Polyhydramnios, Poor Sucking Reflex, Pre-Eclampsia, Premature Baby, Premature Labour, Pulmonary Valve Stenosis, Pupillary Reflex Impaired, Respiratory Disorder Neonatal, Reticulocyte Count Abnormal, Retrognathia, Sciatica, Sinus Tachycardia, Skeleton Dysplasia, Skin Discolouration, Sleep Apnoea Syndrome, Somnolence Neonatal, Suicide Attempt, Tremor Neonatal, Tricuspid Valve Incompetence, Ultrasound Scan Abnormal, Vomiting, Weight Decreased, White Blood Cell Count Increased

Clomipramine Adverse Reaction Definitions
Abortion Spontaneous	Miscarriage means loss of an embryo or fetus before the 20th week of pregnancy. Most miscarriages occur during the first 14 weeks of pregnancy. The medical term for miscarriage is spontaneous abortion.
Anomaly	Something that deviates from what is standard, normal or expected (Congenital Anomaly).
Atrial Septal Defect	An atrial septal defect (ASD), a congenital defect, occurs when there is an opening in the atrial septum, or dividing wall between the two upper chambers of the heart, known as the right and left atria. Normally, oxygen-poor (blue) blood returns to the right atrium from the body, travels to the right ventricle, then is pumped into the lungs where it receives oxygen. Oxygen-rich (red) blood returns to the left atrium from the lungs, passes into the left ventricle, then is pumped out to the body through the aorta. An atrial septal defect allows oxygen-rich (red) blood to pass from the left atrium through the opening in the septum, and then mix with oxygen-poor (blue) blood in the right atrium. This heart defect can cause lung problems if not repaired. When blood passes through the ASD from the left atrium to the right atrium, a larger volume of blood than normal must be handled by the right side of the heart, causing the right side to become overworked and enlarged. Extra blood then passes through the pulmonary artery into the lungs, causing higher pressure than normal in the blood vessels in the lungs, a condition known as pulmonary hypertension.
Clonus	An abnormality in neuromuscular activity characterized by rapidly alternating muscular contraction and relaxation.
Congenital	A physical abnormality that is present at birth.
Congenital Hydrocephalus	Hydrocephalus is an abnormal expansion of cavities (ventricles) within the brain that is caused by the accumulation of cerebrospinal fluid, the result of an imbalance between the formation and drainage of cerebrospinal fluid (CSF). Approximately 500 milliliters (about a pint) of CSF is formed within the brain each day, by epidermal cells in structures collectively called the choroid plexus. These cells line chambers called ventricles that are located within the brain. There are four ventricles in a human brain. Once formed, CSF usually circulates among all the ventricles before it is absorbed and returned to the circulatory system. Because production is independent of absorption, reduced absorption causes CSF to accumulate within the ventricles leading to an elevation of the CSF pressure within the brain. This increased pressure pushes aside the soft tissues of the brain. This squeezes and distorts them. This process also results in damage to these tissues. [Images]
Drug Withdrawal Syndrome Neonatal	Refers to the characteristic signs and symptoms that appear when a drug that causes physical dependence is regularly used for a long time and then suddenly discontinued or decreased in dosage. Also known as abstinence syndrome. A group of unpleasant symptoms produced by the abrupt termination of drug taking. These symptoms, commonly called withdrawal symptoms, include anxiety, muscle weakness, nausea, vomiting, tremor, and a rapid heart beat.
Dyspepsia	Painful, difficult, or disturbed digestion, which may be accompanied by symptoms such as nausea and vomiting, heartburn, bloating, and stomach discomfort.
Facial Dysmorphism	An anatomical malformation of the face. [Images]
Fallot's Tetralogy	A congenital malformation of the heart characterized by a defect in the ventricular septum, misplacement of the origin of the aorta, narrowing of the pulmonary artery, and enlargement of the right ventricle. [Images]
Gastrooesophageal Reflux Disease	A chronic condition (GERD) in which the lower esophageal sphincter allows gastric acids to reflux into the esophagus, causing heartburn, acid indigestion, and possible injury to the esophageal lining.
Gestational Diabetes	Gestational diabetes is a condition that occurs during pregnancy. Like other forms of diabetes, gestational diabetes involves a defect in the way the body processes and uses sugars (glucose) in the diet.
	In diabetes, blood levels of glucose remain abnormally high. In many forms of diabetes, this is because the pancreas does not produce enough insulin.
	In gestational diabetes, the pancreas is not at fault. Instead, the problem is in the placenta. During pregnancy, the placenta provides the baby with nourishment. It also produces a number of hormones that interfere with the body's usual response to insulin. This condition is referred to as "insulin resistance." Most pregnant women do not suffer from gestational diabetes, because the pancreas works to produce extra quantities of insulin in order to compensate for insulin resistance. However, when a woman's pancreas cannot produce enough extra insulin, blood levels of glucose stay abnormally high, and the woman is considered to have gestational diabetes.
Holt-Oram Syndrome	Holt-Oram syndrome is a disorder that affects bones in the arms and hands (the upper limbs) and may also cause heart problems. All people with this disorder have at least one limb abnormality that affects bones in the wrist (carpal bones). Often, these wrist bone abnormalities can be detected only by X-ray. Affected individuals may have additional bone abnormalities that can include a missing thumb or a thumb that looks like a finger, partial or complete absence of bones in the forearm, an underdeveloped bone of the upper arm, and abnormalities that affect the collar bone and shoulder blades. Bone abnormalities may affect each arm differently, and the left side can be affected more than the right side. In some cases, only one arm and/or hand is affected. About 75 percent of individuals with Holt-Oram syndrome have heart problems. The most common problem is a defect in the muscular wall, or septum, that separates the right and left sides of the heart. Atrial septal defects (ASD) are caused by a hole in the septum between the left and right upper chambers of the heart (atria), and ventricular septal defects (VSD) are caused by a hole in the septum between the left and right lower chambers of the heart (ventricles). [Images]
Hydrocephalus	Hydrocephalus is an abnormal expansion of cavities (ventricles) within the brain that is caused by the accumulation of cerebrospinal fluid.
Hypertonia	Extreme tension of the muscles or arteries.
Hypotonia	Decease of normal tonicity (normal firmness or functional readiness in body tissues or organs) or tension.
Opisthotonus	A condition, caused by a tetanic (muscle) spasm of the back muscles, in which the trunk is arched forward while the head and lower limbs are bent backward. [Images]
Pre-Eclampsia	Abnormal state of pregnancy characterized by hypertension and fluid retention and albuminuria (the presence of albumin in the urine, sometimes indicating kidney disease); if untreated, can lead to eclampsia (coma and convulsions before, during, or shortly after childbirth, characterized by edema, hypertension, and proteinuria).
Sciatica	Sciatica refers to pain or discomfort associated with the sciatic nerve. This nerve runs from the lower part of the spinal cord, down the back of the leg, to the foot. Injury to or pressure on the sciatic nerve can cause the characteristic pain of sciatica: a sharp or burning pain that radiates from the lower back or hip, possibly following the path of the sciatic nerve to the foot.
Ventricular Septal Defect	A ventricular septal defect is a hole in the wall of the heart (septum) that separates the left lower chamber (left ventricle) from the right lower chamber (right ventricle). The hole allows blood to flow from the left ventricle to the right ventricle instead of entering the aorta for distribution throughout the body. Ventricular septal defect is one of a group of heart problems found in newborn babies that are collectively called congenital heart disease.

MedWatch is the Food and Drug Administration's program for reporting any undesirable experience associated with the use of a medical product. If you think you or someone in your family has experienced an adverse reaction from taking Clomipramine and it has not been reported to the FDA, see this page for instructions on reporting the adverse event through your doctor or directly to the FDA using an online form.

A May 2006 USA Today article states that "drug companies are required to file any reports they have to the FDA, but consumers and doctors report such events on a voluntary basis. Studies suggest the FDA's Adverse Events Reporting System database captures only 1% to 10% of drug-induced side effects and deaths, "maybe even less than 1%," says clinical pharmacologist Alastair J.J. Wood, an associate dean at Vanderbilt Medical School in Nashville. So the real number of cases is almost certainly much higher".